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FDA Issues Draft Guidance on Quantitative Imaging Medical/Dental Devices

The United States Food and Drug Administration (FDA) has issued draft guidance on quantitative imaging medical/dental devices.  The FDA notes that as medical/dental imaging continues to evolve, quantitative imaging – the extraction of information from medical/dental images in the form of numerical values – is increasingly used to assess the severity, degree of change, or status of a disease, injury, or condition.  To read the FDA draft guidance on quantitative imaging medical/dental devices, use the link below.